21 CFR Part 820 QSR with Updated 2026 QMSR

21 CFR Part 820 Quality System Regulation and 2026 Updated Quality Management System Regulation (2-February 2024 Update)

21 CFR Part 820 Quality System Regulation 

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

PART 820 -- QUALITY MANAGEMENT SYSTEM REGULATION
SUMMARY: The FDA is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation.

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21CFR820QSR-820QMSR-C-251219